Industry standard of Ginkgo biloba leaves extraction to be improved

After more than a year, the "ginkgo leaf storm" finally came to an end Recently, the State Food and Drug Administration announced the results of the treatment of enterprises that illegally produce and sell Ginkgo biloba extract and preparations 65 pharmaceutical enterprises involved were respectively punished by revoking the drug production license, revoking the drug approval certificate, warning of fines, and requesting the local government to shut down, with a total fine of more than 100 million yuan Shandong Shuanghua Pharmaceutical Co., Ltd., Yantai Rongchang Pharmaceutical Co., Ltd., Lunan Houpu Pharmaceutical Co., Ltd and Shandong Baicao Pharmaceutical Co., Ltd are involved in the affairs of four enterprises in our province, and have been given such penalties as revocation of drug production license and fine Since May last year, the State Food and drug administration has carried out a nationwide special treatment action on Ginkgo biloba extract and preparations 90 pharmaceutical manufacturers using ginkgo biloba extract as pharmaceutical raw materials have been ordered to self inspect After investigation, 59 enterprises were punished according to law for producing fake and inferior drugs Among them, there are 4 drug production licenses revoked, 4 drug approval documents to be revoked, 47 administrative penalties such as fines, with a total amount of 103 million yuan of fines and confiscations, and 4 enterprises without drug production qualification are requested to be shut down by the local government Among the above-mentioned enterprises, 8 were transferred to public security organs for suspected crimes; 7 were punished for their qualification of not engaging in drug production and trading activities within 10 years; 6 were exempted or not given administrative punishment There are 4 pharmaceutical manufacturing enterprises involved in our province, namely: Shandong Shuanghua Pharmaceutical Co., Ltd purchases Ginkgo biloba extract produced by unqualified enterprises and sells it to the outside after being labeled, resulting in the drugs produced by downstream pharmaceutical enterprises being identified as fake drugs and substandard drugs, with serious violations, the pharmaceutical production license being revoked and a fine being imposed Yantai Rongchang Pharmaceutical Co., Ltd., Lunan Houpu Pharmaceutical Co., Ltd and Shandong Baicao Pharmaceutical Co., Ltd illegally produce fake Ginkgo biloba preparations, which are subject to administrative penalties such as confiscation of illegal products, illegal income and fines by local food and drug regulatory authorities It is one of the main problems found in the national inspection to extract Ginkgo biloba leaves with dilute hydrochloric acid instead of dilute ethylene "Preparation of Ginkgo biloba extract with dilute hydrochloric acid can reduce the cost by 3000-4000 yuan per ton, and the yield will be greatly increased." In order to reduce costs and improve efficiency, this "process" once became a "hidden rule" in the ginkgo leaf extraction industry, said the head of the production department of a pharmaceutical enterprise in Sichuan Province The effective components of Ginkgo biloba extract extracted by dilute hydrochloric acid decreased, and the content of harmful substances such as ginkgolic acid increased, which greatly affected the effect and safety of the product Behind the disorder of ginkgo leaf extraction is the lack of industry standards Zhang Bin, an analyst in Zhuo Chuang information's traditional Chinese medicine industry, said that unlike the industry standards and industry specifications of traditional Chinese medicine raw materials and decoction pieces, there is no clear industry standard for plant extracts The requirements for ginkgo leaf extraction, production specifications and testing standards mentioned in the Pharmacopoeia are just a guiding outline, which is difficult to guide and regulate the production of enterprises "Due to the lack of industry norms, the production level of enterprises is uneven, and the circulation order is chaotic, which restricts the development of the industry." It is reported that at present, the industry standard of plant extraction industry, including ginkgo leaf extraction, is being formulated, which may be the harvest brought by the "ginkgo leaf storm".